Over the counter options for male sexual enhancement got slimmed by four this week as Gadget Island recalled four male sexual enhancement products.
The problem isn’t that Grande X 5800; Papa Zen 3300; Fifty Shades 6000; and Rhino 7 Platinum 5000 don’t work. What got all one-capsule lots of three products and lot No. NSS050888 of Papa Zen recalled is they contain some of the ingredients that work in FDA approved prescription drugs Viagra (sildenafil) and Cialis (tadalafil).
The recall notice states, “FDA analysis has found the products to be tainted with sildenafil and tadalafil, which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED), as well as Desmethyl Carbodenafil, which is structurally similar to sildenafil.”
So, the pills count as “unapproved drugs” because their safety and effectiveness haven’t been established. The recall notice’s risk statement lays out the same hazards that the voiceovers in Viagra and Cialis commercials do — the combination of these pills with nitrates in some prescription drugs can cause a potentially fatal drop in blood pressure. And, in the case of these pills, the “FDA has received adverse event reports from consumers who have purchased these products.”
Bad reactions from this product should be reported to your doctor and can be reported to the FDA online or calling 1-800-332-1088 for a faxable reporting form. Those wanting to talk to the company can call customer service at 1-888-387-4753 or e-mail firstname.lastname@example.org 1 p.m. to 7 p.m. Eastern time, Monday through Friday.